Introducer with radiopaque marked tip and method of manufacture therefor

Abstract

A medical vascular introducer of the type having an elongated hollow shaft, a distal portion of which is insertable into the body of a patient, wherein the improvement comprises a pair of radiopaque markers disposed at two longitudinally distinct positions on the exterior of the shaft, the markers being separated a predetermined longitudinal distance. Also disclosed is a marker design which is circumferentially discontinuous and consists of at least one marker segment and at least one void area.

The invention claimed is: 
     
       1. A medical vascular introducer of the type having an elongated hollow shaft with proximal and distal portions, said distal portion being insertable into the body of a patient, wherein the improvement comprises at least one marker disposed on the exterior of said shaft, said at least one marker being constructed of a circumferentially discontinuous band of radiopaque material comprising at least two marker segments, said marker segments being circumferentially separated from each other by void areas of said shaft, whereby said void areas permit expansion and contraction of said radiopaque material with respect to said shaft. 
     
     
       2. A medical vascular introducer of the type having an elongated hollow shaft with proximal and distal portions, and a distal tip, the distal portion being insertable into the body of a patient, wherein the improvement comprises a pair of markers disposed at two longitudinally distinct positions on the exterior of the shaft, said markers being separated a predetermined longitudinal distance, said markers being constructed of circumferentially discontinuous bands of a radiopaque metallic substance consisting of three marker segments and three void areas. 
     
     
       3. The introducer of claim 2, wherein a first marker is disposed at the distal tip of the shaft and wherein a second marker is disposed proximally with respect to said first marker. 
     
     
       4. The introducer of claim 2, wherein said predetermined longitudinal distance is 0.787±0.020 inches. 
     
     
       5. The introducer of claim 2, wherein the shaft is constructed of FEP, and wherein said metallic substance is selected from the group of substances consisting of titanium, stainless steel, copper, gold, silver and platinum, said metallic substance being deposited by a coating process. 
     
     
       6. The introducer of claim 2, wherein the shaft is constructed of HDPE, and wherein said markers are constructed of gold deposited by a coating process. 
     
     
       7. The introducer of claim 2, wherein said marker bands have a width of 0.05-0.08 inches. 
     
     
       8. The introducer of claim 2, wherein the medical vascular introducer is a hemostasis introducer comprising the shaft, the shaft having a lumen, a housing disposed at a proximal end of the shaft, a valve disposed in the housing, transaxially with respect to the lumen of the shaft, and means to relieve strain between the shaft and the housing. 
     
     
       9. A medical vascular introducer of the type having an elongated hollow shaft with proximal and distal portions, and a distal tip, the distal portion being insertable into the body of a patient, wherein the improvement comprises at least one marker disposed on the exterior of the shaft, said marker being constructed of a circumferentially discontinuous band of radiopaque material consisting of three marker segments and three void areas. 
     
     
       10. The introducer of claim 9, wherein there are a pair of markers disposed at two longitudinally distinct positions on the shaft, said markers being separated a predetermined longitudinal distance. 
     
     
       11. The introducer of claim 10, wherein a first marker is disposed at the distal tip of the shaft and wherein a second marker is disposed proximally with respect to said first marker. 
     
     
       12. The introducer of claim 10, wherein said predetermined longitudinal distance is 0.787±0.020 inches. 
     
     
       13. The introducer of claim 9, wherein the shaft is constructed of FEP, and wherein said radiopaque is a metallic substance selected from the group of substances consisting of titanium, stainless steel, copper, gold, silver, and platinum, said metallic substance being deposited by a coating process. 
     
     
       14. The introducer of claim 9, wherein the shaft is constructed of HDPE, and wherein said marker is constructed of gold deposited by a coating process. 
     
     
       15. The introducer of claim 9, wherein said at least one marker segment has a width of 0.05-0.08 inches. 
     
     
       16. The introducer of claim 9, wherein the medical vascular introducer is a hemostasis introducer comprising the shaft, the shaft having a lumen, a housing disposed at a proximal end of the shaft, a valve disposed in the housing, transaxially with respect to the lumen of the shaft, and means to relieve strain between the shaft and the housing. 
     
     
       17. A method of making a medical introducer comprising the steps of: (a) providing an elongated, hollow tube constructed of a flexible polymeric material; and   (b) depositing a radiopaque substance at at least one predetermined location on an exterior surface of said tube via sputter coating to form a circumferentially oriented fluoroscopic marker band consisting of three marker segments separated by three void areas.   
     
     
       18. The method of claim 17, wherein a pair of marker bands are deposited at two longitudinally distinct positions on the shaft, said marker bands being separated a predetermined longitudinal distance. 
     
     
       19. The method of claim 17, wherein the shaft is constructed of FEP and wherein said radiopaque substance is a selected from the group consisting of titanium, stainless steel, copper, gold, silver, and platinum. 
     
     
       20. The method of claim 17, wherein the shaft is constructed of HDPE and wherein said radiopaque substance is gold.